NCT02220686

Brief Summary

The purpose of the study is to see if vascular physicians (your provider) using a combination of proven smoking cessation tools in an organized way can help vascular patients quit smoking better than usual. The doctors where you are being treated have been chosen to either provide: the combination therapy of giving you advice, considering prescribing medications to help you quit smoking, and referring you to a phone quitline, or to continue their usual smoking cessation practices (which may include all, some, or none of the treatments above).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

1.6 years

First QC Date

August 14, 2014

Last Update Submit

July 25, 2017

Conditions

Keywords

VAPORsmoking cessationPAD

Outcome Measures

Primary Outcomes (1)

  • Efficacy of the "Offer and Report" protocol for change in smoking status from Baseline Visit to 3 Month Visit

    To assess the efficacy of the "Offer and Report" protocol (standardized (1) "very brief advice," (2) referral to telephone-based smoking cessation counseling, and (3) consideration of prescribing nicotine replacement therapy (NRT)) as compared to usual smoking cessation care by vascular physicians in biochemically-validated 3 month smoking cessation rates. A questionnaire will be completed by the patient at the Baseline visit and another questionnaire will be completed at the 3 month visit to assess the change in smoking status.

    Change in smoking status from Baseline Visit to 3 Month Visit

Study Arms (2)

Offer and Report Protocol

EXPERIMENTAL

Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.

Behavioral: Offer and Report Protocol

Usual Care

NO INTERVENTION

Physician will follow their institution's standard of care for smoking cessation.

Interventions

Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.

Offer and Report Protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18
  • Current smoker
  • Plan to have a Vascular Quality Initiative (VQI) procedure in \> 7 days

You may not qualify if:

  • Pregnant Women, Fetuses and Neonates
  • Children
  • People with impaired decision-making capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UF Health

Gainesville, Florida, 32610-0128, United States

Location

Northwestern Memorial

Chicago, Illinois, 60611, United States

Location

University Health

Shreveport, Louisiana, 71130, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

UMASS Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Roper Hospital

Charleston, South Carolina, 29401, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

  • Spangler EL, Brooke BS, Beck AW, Hoel A, Farber A, Goodney PP; VAPOR Trial Investigators. Design and initial enrollment in the Vascular Physicians Offer and Report (VAPOR) trial. J Vasc Surg. 2016 Apr;63(4):1121-5.e2. doi: 10.1016/j.jvs.2015.12.026.

MeSH Terms

Conditions

Peripheral Arterial DiseaseSmoking Cessation

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesHealth BehaviorBehavior

Study Officials

  • Philip Goodney, MD, MS

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR
  • Alik Farber, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 20, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations